A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria.
Indian J Dermatol Venereol Leprol
;
2014 Mar-Apr; 80(2): 122-128
Artigo
em Inglês
| IMSEAR
| ID: sea-154762
ABSTRACT
Background:
Chronic urticaria not responsive to antihistamines is a diffi cult disease to manage. Methotrexate has been used in diffi cult chronic urticarias with some benefi t.Objective:
To evaluate the effi cacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics.Methods:
In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre, 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited. Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo (calcium carbonate) for a total duration of 12 weeks, after which treatment was stopped and patients were followed up for relapse of urticaria. Each group also received levocetrizine 5 mg once daily for symptom control. Primary outcome measured was a reduction by >2/3rd of baseline urticaria scores after 12 week therapy. Secondary outcome was a reduction in antihistamine requirement after stopping therapy.Results:
Fourteen patients were randomized to the methotrexate group and fi fteen patients to the placebo group. Out of 17 patients who completed therapy, the primary outcome was achieved by 3.5 ± 1.9 (out of 10) patients in the methotrexate group and by 3.67 ± 1.03 (out of 7) patients in the placebo group (P > 0.05). Ten patients followed up, after stopping therapy, for a mean period of 3.5 ± 2.4 months; 3 remained in remission and 7 had relapsed. One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study. The placebo group did not experience any side effects.Conclusions:
Methotrexate 15 mg weekly for 3 months did not provide any additional benefi t over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Assunto principal:
Placebos
/
Urticária
/
Feminino
/
Humanos
/
Masculino
/
Resistência a Medicamentos
/
Projetos Piloto
/
Metotrexato
/
Método Duplo-Cego
/
Doença Crônica
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo observacional
/
Estudo prognóstico
Idioma:
Inglês
Revista:
Indian J Dermatol Venereol Leprol
Ano de publicação:
2014
Tipo de documento:
Artigo
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